Clearance Summary
VANGUARD REPROCESSED INFLATION DEVICES received FDA 510(k) clearance under submission number K012480, sponsored by Vanguard Medical Concepts, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-01-22.
- Submission: K012480
- Applicant / Sponsor: Vanguard Medical Concepts, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2002-01-22
Classification & Regulation
This clearance is catalogued under FDA product code MAV and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.